OncoMatch/Clinical Trials/NCT07172958
Selective Antigen Specific T Cells and CAR T Cells in Subjects With Relapsed/Refractory Embryonal Tumors (SABRE)
Is NCT07172958 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Selective Antigen Specific dTβRII-expressing T cells combined with B7-H3 CAR T cells for rhabdomyosarcoma.
Treatment: Selective Antigen Specific dTβRII-expressing T cells combined with B7-H3 CAR T cells — This is a phase I dose-escalation study to determine the safety and feasibility of autologous CAR-TA T cells (B7-H3 CAR+ T cells administered with DNR-PRAME Tumor Antigen-specific T cells) following lymphodepleting chemotherapy in participants with relapsed/refractory rhabdomyosarcoma, Ewing sarcoma, neuroblastoma and Wilms tumor. Patients will be enrolled to one of three planned dose levels with B7-H3 CAR T cell dose determined based on the percentage of B7-H3 transduced cells (B7-H3+ population of cells), and dTBRII-transduced PRAME TA-specific T cell dose based on the total cell population. Both doses will be based on the recipient's body weight. The safety of the CAR-TA T cell product will be evaluated and the maximum tolerated dose (MTD) will be determined. The safety endpoint will be assessed by monitoring for dose limiting toxicities for 28 days following CAR-TA T cell administration.
Check if I qualifyExtracted eligibility criteria
Cancer type
Rhabdomyosarcoma
Sarcoma
Neuroblastoma
Lab requirements
Blood counts
ANC > 500/b5L (procurement), > 750/b5L (infusion); ALC > 1000/b5L (procurement); Platelet count > 50,000/b5L (procurement), > 75,000/b5L (infusion)
Kidney function
Serum creatinine (age/sex-based thresholds) OR Creatinine clearance or GFR 70 mL/min/1.73 m^2
Liver function
Bilirubin 2.5 mg/dL; AST/ALT 5x the upper limit of normal for age
Cardiac function
Shortening fraction 27% by echocardiogram, or ejection fraction > 50% by echocardiogram or radionuclide angiogram
Bilirubin 2.5 mg/dL; AST/ALT 5x the upper limit of normal for age; Serum creatinine (age/sex-based thresholds) OR Creatinine clearance or GFR 70 mL/min/1.73 m^2; ANC > 500/b5L (procurement), > 750/b5L (infusion); ALC > 1000/b5L (procurement); Platelet count > 50,000/b5L (procurement), > 75,000/b5L (infusion); Shortening fraction 27% by echocardiogram, or ejection fraction > 50% by echocardiogram or radionuclide angiogram
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's National Hospital · Washington D.C., District of Columbia
- Childrens National Hospital · Washington D.C., District of Columbia
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